This application is a Continuation-in-part of application Ser. No. 09/473,138 filed on Dec. 28, 1999.
The present invention relates to record and verify systems used in medical treatments and, more particularly, to an improved record and verification system for such use which includes a number of important features and advantages as compared with prior art systems including those currently in use.
By way of background, it is instructive to briefly consider the history of verify and record systems used in connection with radiation therapy treatment of patients using linear accelerators or other megavoltage radiation units. Verify and record systems were originally designed to verify that radiation treatments were set up correctly by the radiation therapy technologist (RTT). This was accomplished through verification that certain key parameters were within predetermined tolerances. The verify and record process has evolved more recently into an automated set-up procedure that emphasizes rapid through-put, while de-emphasizing verification of treatment parameters that previously were set manually by the RTT. Some record and verify systems currently in use actually take control of the manual process by changing physician-selected field sizes, even though the field sizes fall within selected tolerance limits. The trend toward automated systems has led to reduced interaction between the user and the accelerator which has both positive and negative implications. The philosophy of delivering radiation treatment based on an automated set-up model is grounded in the desire to reduce the potential for human error in the set-up process. The downside of the automated or xe2x80x9cblack boxxe2x80x9d approach is the disengagement of the RTT from parameter adjustment, i.e., in relieving the RTT of the task of setting the patient treatment parameters through adjustment of the linear accelerator. The negative aspect of this is that if the RTT does not have to set the parameters manually, the RTT is less conditioned to perform the function manually and, therefore, less conditioned to detect errors when these errors occur, whether these errors are dosimetry programming or process errors and whether these errors occur in manual or automated set-up modes. When the RTT is detached from the procedure of manually setting up the patient for treatment, it becomes more difficult for the overall treatment process to recover should the automated process fail. In this regard, when an RTT sets up a patient manually, the RTT xe2x80x9crehearsesxe2x80x9d the recovery procedure that would be used if the automated primary process should fail. However, when automated set-ups are employed, the RTT is less xe2x80x9crehearsedxe2x80x9d in recovering efficiently when the automated process is not available, because such rehearsal of recovery procedures is not integral to automated treatment delivery. The more safety critical the task, the more the recovery should be rehearsed.
Given current trends in the medical industry, the trend toward automated set-up is irreversible. Further, because of a number of factors including cost pressures, the trend toward staffing reduction is irreversible, at least in the near term. It also appears clear that the electronic record will not totally replace the paper chart, at least not in the near term. In this regard, even if it were proven better for patient care to chart electronically, physician resistance will hinder widespread adoption in the foreseeable future. In general, physicians will not abandon paper charts, either from habit or for medical-legal reasons. Accordingly, the need for maintaining a paper record during implementation of electronic medical record keeping will continue. As a consequence, a further vulnerability of automated radiation treatment systems (in addition to the disengagement of the RTT from the manual recovery process when the automated system is temporarily down), is the potential for mismatches between the electronic record and the paper medical record. These mismatches are commonly due to a failure of the RTT to document treatments in the paper record when the automated system logs the event. The problem of electronic record and paper mismatches is increasing in the specialty of radiation oncology, as reported by clinical medical physicists.
It should be understood that disengagement of the RTT from the manual recovery process increases risk for patient care because the verify and record systems, in many recent configurations, do not check for human error. Record and verify systems, when programmed and executed correctly, can prevent some errors, but not all. Record and verify systems in current use cannot detect human errors when the system itself is the primary process. Additionally, as indicated above, the disengagement of the RTT from linear accelerator parameter adjustment also can disengage the RTT from subtle cues regarding patient identification and radiation field placement. It would be desirable if record and verify systems were configurable to allow automated set-ups at selected times for certain radiation therapy technologists and not for others, such as, for example, when the manual skills of selected RTTs are being assessed. However, the overall trend is clearly toward automated set-up because of the improved throughput which results, as well as the industry-wide momentum toward multi-leaf collimator therapy, which is more optimally performed with automation.
Greater automated throughput can lead to greater risk for other reasons as well. Increased automation means greater potential for a mistake occurring through dose calculation error, with the danger of the error being repeated without prompt detection once the error does occur. The emphasis on throughput also increases the probability of errors in the actual treatment process, characterized by patient identification errors, field sequence errors and field alignment errors. Major preventable ways to harm patients through treatment process failures include (1) treating the wrong patient, i.e., treating a patient with a radiation treatment intended for another patient; (2) treating the right patient, but on a day when the patient is not supposed to receive treatment until other evaluations are performed first (e.g., treating a patient when the patient should have been seen by the doctor prior to the treatment delivery), and (3) treating the right patient but with the improper treatment set-up, i.e., treating with a wedged field without a wedge, treating with the wrong monitor units (MU) programmed into the accelerator, or treating with the wrong energy. In addition, as described above, in the event that the record and verify device should be temporarily unavailable due to a network, or other, problem, there is a distinct possibility or even an increased probability of parameter selection errors due to human error, because the process of automation can change the behavior of the user, making the user more dependent on automation. It is noted that more combination chemotherapy with radiation increases toxicity and therefore increases the potential harm that may occur to a patient if the patient receives the wrong treatment or if the patient is treated without proper evaluation before treatment. Moreover, pushing patients to the limit of tissue tolerance increases the potential for adverse events. Automated treatment may increase the possibility of undetected mistakes related to automated set-up, thereby increasing the possibility of patient injury.
As indicated above, the transition to automated treatment system tends to distract the RTTs for a number of reasons. First, and very basically, the new technology creates a new process. Further, the new process diverts RTTs from traditional cross checks in the treatment room. This is true of systems now in use such as the VARIS, IMPAC and LANTIS systems. In addition, visual distractions are created and the RTTs are diverted from paper chart documentation which can be critical in the safe treatment of a patient.
Although the focus above has been on radiation therapy, it will be appreciated that similar problems exist in other medical treatment settings including chemotherapy as well as in neonatal care, dispensing of medications on both an inpatient and outpatient basis and in other inpatient and outpatient applications wherein patient verification, medication verification, medication delivery device verification and the like are of importance.
In accordance with the invention, a record and verify method is provided which addresses the issues discussed above. Among other advantages, the method of the invention assists in verification of patient identity, and, according to an important feature, enlists the patient in the identification process. The invention also documents electronically and manually which RTT was responsible for final parameter verification, including documenting the treated patient, and time of cross-check, and thus avoiding electronic record and paper record mismatches. The patient identification component is installed at a workstation and functions even if the system network is down, thereby maintaining an accountability trail as part of the recovery procedure from network failure.
In accordance with a first aspect of the invention, a method is provided for verification of the identification of a patient undergoing radiation treatment administered by a treatment technologist in a treatment room using a radiation source, the method comprising:
providing an identifying card for the patient including an identifying optical code capable of being read by an optical reader located within the treatment room;
causing the identifying card to be read by said optical reader in the treatment room;
generating a characteristic audio signal, previously assigned to the patient and known to the patient and the treatment technologist, in response to the reading of the identifying card when there is a match between the identifying optical code and a stored identifying code for the patient; and
at least temporarily withholding treatment of the patient if the patient and technologist do not agree that any audio signal generated is the characteristic audio signal assigned to the patient.
In an advantageous implementation, the identifying card includes a photograph of the patient and the photograph is used by the technologist in identifying the patient.
Preferably, the identification card is affixed to a treatment file containing treatment data for use by the technologist during treatment, and the card affixed to the treatment file is caused to be read by the technologist thereby ensuring that the technologist takes the treatment file into the treatment room.
In a preferred embodiment, the method further comprises generating an electronic record comprising treatment data associated with the treatment to be administered and including said identifying optical code, causing the identifying optical code of the electronic record to be read by a further optical reader in the treatment room, generating said characteristic audio signal in response to reading of said identifying code of the electronic record, and at least temporarily withholding treatment if the patient and the technologist do not agree that any audio signal generated in response to the reading of the identifying code of the electronic record is the characteristic audio signal assigned to the patient. Advantageously, the optical readers are caused to read the respective optical codes of the card and the electronic record at closely spaced times. Advantageously, the respective optical codes are caused to be read by different technologists. In an advantageous embodiment, the optical readers are located on opposite walls of the treatment room. Preferably, the optical readers are each a part of respective verification stations located at different locations inside of the treatment room and the stored identifying code is stored at a verification workstation located outside of the treatment room and linked to the respective verification stations.
More generally, where there is only one optical reader inside the treatment room, the optical reader is preferably part of a first verification station located inside of the treatment room and the stored identifying code is stored at a verification workstation located outside of the treatment room and linked to the verification station inside the treatment room.
In accordance with a further aspect of the invention which combines some of the features discussed above, a method is provided for identification, and verification of the identification, of a patient undergoing radiation treatment by a radiation source administered by a treatment technologist in a treatment room, the method comprising:
providing a treatment file for the patient to be treated containing a prescribed treatment regimen for the patient;
providing an identifying card affixed to the treatment file and including a photograph of the patient together with an identifying optical code capable of being read by an optical reader located within the treatment room;
causing the identifying card of the treatment file to be read by the optical reader in the treatment room;
generating a characteristic audio signal known to the patient and the treatment technologist in response to the reading of the identifying card when there is a match between the identifying optical code and a stored identifying code for the patient; and
providing for checking of the treatment file by the technologist if the patient and technologist do not agree that the audio signal generated is the characteristic audio signal assigned to the patient.
As with the method above, the method of this aspect of the invention preferably comprises generating an electronic record comprising treatment data associated with the treatment to be administered and including said identifying optical code, causing the identifying optical code of the electronic record to be read by a further optical reader in the treatment room, generating said characteristic audio signal in response to reading of said identifying code of the electronic record, and checking the treatment file and at least temporarily withholding treatment by the technologist if the patient and the technologist do not agree that any audio signal generated in response to said reading of the identifying code of the electronic record is the characteristic audio signal assigned to the patient. As above, the optical readers are preferably caused to read the respective optical codes of the card and the electronic record at closely spaced times, and, in an advantageous implementation, are caused to be read by different technologists.
As discussed in connection with the first aspect of the invention, the optical readers are preferably located on opposite walls of the treatment room. More generally, the optical readers are each a part of respective verification stations located at different locations inside of the treatment room and, advantageously, the stored identifying code is stored at a verification workstation located outside of the treatment room and linked to the respective verification stations.
In accordance with yet another aspect of the invention, a record and verify method for use with a radiation therapy system including, located in a treatment room, a radiation treatment device for providing radiation treatment and a treatment monitor for monitoring the treatment provided by the treatment device, the method comprising:
using a patient chart for a patient to be treated to enter treatment data into the treatment monitor;
retrieving stored treatment data for use at a verification monitor;
sending the entered treatment data to the verification monitor for comparison with the stored treatment data;
comparing each data entry of the entered treatment data with a corresponding stored data point of the stored treatment data;
using the verification monitor to output an identifier for each data entry which, based on said comparison, is outside of predetermined tolerances;
correcting, as necessary, the data entered into the treatment monitor based on the output received from said verification monitor to produce corrected treatment data;
generating an electronic record of the corrected treatment data;
using a high speed printer to print the prescribed treatment data on a paper verification sheet;
cross-checking the corrected treatment data with previous treatment data;
when the printed paper verification sheet is checked and determined to be accurate, using the radiation treatment device in treating the patient so as to generate actual core treatment data;
printing said actual treatment data on the verification sheet to produce an updated verification sheet;
after completion of a final treatment field of the radiation treatment, reviewing and signing off on the updated verification sheet;
manually entering the actual data obtained from the treatment monitor into the patient""s chart and reviewing and signing off on the manual entry of the actual data on the patient""s chart; and
checking the core treatment data on the printed hard copy against the actual treatment data entered into the patient""s chart and, if there is agreement, signing off on the patient""s chart and the paper verification sheet.
Preferably, first and second radiation technologists carry out the method, and the first therapist is responsible for steps (a), (c), (f), (j) and (m) and the second therapist is responsible for steps (a), (b), (d), (e), (g), (h), (i), (k), (l) and (n). Advantageously, the first therapist also reviews and signs off on the paper verification sheet upon completion of the method.
In accordance with still a further aspect of the invention, a treatment verification method is provided for use with a radiation therapy system including a radiation treatment device for providing radiation treatment, the method comprising:
providing automated and manual set up options for setting of treatment field values for the radiation treatment device wherein, in the automated option, treatment field values are automatically entered as received from a computer at a verification station and wherein, in the manual option, the treatment field values are entered by a technologist at a radiation treatment device workstation;
setting different predetermined tolerances based on whether the treatment field values are to be entered in an automated manner by the computer in accordance with said automated option or are to be entered manually by the technologist in accordance with said manual option;
selecting between said options and proceeding with the selected option;
comparing each data entry for the entered treatment field values with a corresponding stored data point of stored treatment field values; and
using the verification monitor to output an identifier for each data entry which, based on said comparison, is outside of the predetermined tolerances for the option selected.
In accordance with yet another aspect of the invention, a verification system is provided for use in verification of the identity of a patient about to undergo radiation treatment administered to the patient by radiation source in a treatment room under the control of at least one treatment therapist and monitored by a treatment monitor located in the treatment room, said system comprising:
a verification workstation, located outside of the treatment room, including means for storing a patient identifying code for the patient; and
at least one verification station linked to said verification workstation and located within the treatment room at spaced locations on opposite sides of the radiation source, said at least one verification station including an optical reader and means for generating an audible output assigned to the patient, responsive to said optical reader reading a patient identifying code assigned to the patient that matches the patient identifying code stored at the verification workstation.
Preferably, first and second verification stations are provided which are located within the treatment room at spaced locations on opposite sides of the radiation source.
In accordance with a further aspect of the invention, a method is provided for verification of the identity of a patient, the method comprising: scanning a patient identifier which identifies the patient to be treated; and generating a characteristic audio signal, previously assigned to the patient, in response to the scanning of the patient identifier when there is a match between the scanned patient identifier and a stored identifier for the patient.
Preferably, the audio signal is known to at least one of (i) the patient and (ii) an authorized caregiver for the patient.
In one implementation wherein the patient is undergoing medical treatment, the method further comprises at least temporarily withholding treatment of the patient if any audio signal generated in response to the scanning of the patient identifier is not the characteristic audio signal assigned to the patient.
In an implementation wherein the patient is a newborn baby, the scanning is carried out to ascertain whether the newborn may properly be removed from its current location. Advantageously, an approved caregiver for the baby is assigned a badge including an identifier and the badge must also be scanned by the caregiver before the baby can properly be removed by the caregiver from said current location. Preferably, the patient identifier is also carried by a name card on the bassinet for the baby. Advantageously, the patient identifier is also carried by an identification band worn by the baby.
In a beneficial implementation of the invention, at least one further identifier, in addition to said patient identifier, is scanned for a match and said characteristic audio signal is generated only after a match is found in each instance that an identifier is scanned. Preferably, the characteristic audio signal is generated only when a match is found in each instance and only when the matches occur in a predetermined sequence.
According to a further aspect of the invention, in addition to said scanning of the patient identifier, a caregiver identifier is scanned to determine whether the caregiver identifier is that of an authorized caregiver for the patient and a check sheet identifier is scanned to determine whether the check sheet is that of the patient, and the characteristic audio signal is generated only after a match is provided in every instance. Advantageously, the characteristic audio signal is generated only when the identifiers are scanned in a predetermined sequence. Preferably, a medication identifier associated with a medication about to be given to the patient is also scanned to determine whether the medication is that intended for the patient and a further, matching characteristic audio signal is generated when there is a match.
According to another embodiment of this aspect of the invention, the patient identifier is carried by a medication container for medication for the patient. Preferably, the patient identifier is also carried by a medication chart on which the physician first writes an order for the medication and both the medication container and the mediation chart are scanned to determine whether said characteristic audio signal is generated in response thereto.
In accordance with yet another embodiment of this aspect of the invention, scanning takes place in a patient dwelling and the patient identifier is carried by a container for a medication which is to be taken by the patient and which is prepared by a pharmacy. Advantageously, a prescription for the medication, including the name of the patient, is initially written by a physician for the patient, the prescription is received by the pharmacy, and the pharmacy determines the corresponding scannable patient identifier assigned to the patient and dispenses the medication in said container carrying said patient identifier.
According to a further embodiment of this aspect of the invention, scanning of said patient identifier comprises scanning of a medical device for delivering a medication to the patient. In one important implementation, the medical device comprises a syringe or a similar medication infusion device.
In accordance with still another embodiment of this aspect of the invention, the patient identifier is carried by a label produced by the caregiver. Preferably, the caregiver initially dispenses a plurality of identical patient identifier carrying labels at the same time. In a preferred implementation, the method is used in chemotherapy treatment of the patient and said labels are applied to container for all drugs used in the chemotherapy treatment, to all syringes used in the chemotherapy treatment and to at least one patient identification member.
Preferably, said scanning of patient identifier comprises scanning of a patient identifying member selected from the group consisting of a patient photograph, a patient treatment chart, a patient identification card and an identification band worn by the patient. In an advantageous application, at least two of the patient identifiers of said group are separately scanned.
Preferably, said scanning is carried out using a scanning device selected from the group consisting of a coded marking scanner, a retinal scanner, a fingerprint scanner, an iris scanner and a scanner for a subcutaneous microchip. In a preferred embodiment, said patient identifier comprises a barcode and scanning of said barcode is carried out using a coded marking scanner comprising a barcode reader.
Advantageously, said characteristic audio signal comprises a non-verbal sound pattern. Preferably, the non-verbal sound pattern comprises a three tone chord. In an advantageous implementation, the duration of said chord is about 2 to 3 seconds.
In another important implementation, the chord is generated at two different times, in close sequence, from two spaced locations and the duration of said chord is about xc2xd to 2 seconds.
In accordance with another embodiment of this aspect of the invention, scanning of the patient identifier comprises scanning two different identification members carrying the patient identifier and results in the generation of two separate matching characteristic audio signals at two different spaced apart locations in a treatment room when the patient identifiers carried by the two members match said stored patient identifier. Preferably, the two patient identifiers are scanned by two different separate scanning devices spaced apart in the treatment room.
According to yet another aspect of the invention, a method is provided for verification of the identity of a patient undergoing treatment administered by a medical treatment practitioner in a treatment room, the method comprising: providing an identifying element for the patient including a patient identifier capable of being read by a reader device located within the treatment room; causing the patient identifier to be read by said reader device in the treatment room; generating a characteristic audio signal, previously assigned to the patient and known to the patient, in response to the reading of said identifying element when there is a match between the patient identifier and a stored identifier for the patient; and at least temporarily withholding treatment of the patient if any audio signal generated in response to reading of the patient identifier by the reader device is not the characteristic audio signal assigned to the patient.
Preferably, the identifying element comprises an identifying member selected form the group consisting of a patient photograph, a patient treatment chart, a patient treatment verification sheet, a patient identification card and an identification band worn by the patient. Advantageously, the reader device comprises one of a coded marking reader and a fingerprint scanner.
In a preferred embodiment of this aspect of the invention, the first and second reader devices are provided in the treatment room as part of a workstation which also includes first and second spaced audio speakers for generating said characteristic audio signal, and at least a treatment practitioner is required to scan different patient identifying elements each including said patient identifier at the first and second readers, respectively. Advantageously, one of said patient identifying elements comprises a patient chart including a photograph of the patient. Alternatively, or in addition, one of said patient identifying elements comprises a paper patient treatment verification sheet.
In a further embodiment of this aspect of the invention, two medical practitioners carry out the treatment and wherein the treatment that the patient is to undergo includes an automatic setup portion which is carried out automatically under computer control and access to the automatic setup portion is permitted only if both medical practitioners are designated as having automatic setup privilege. According to a related aspect of this embodiment, the method is used in a control system to control, based on preselected criteria, access to an existing automatic download treatment system for a radiation treatment device which automatically transfers prestored patient treatment parameters to the radiation treatment device. Preferably, said criteria include verification of privileges of the medical practitioners responsive to logging by the practitioners onto the control system by effecting scanning of a patient chart by one of the reader devices.
According to a further embodiment of this aspect of the invention, the patient identifier is carried by a container for a medication for the patient and the characteristic audio signal is known both by the patient and the medical treatment practitioner so that both the patient and the practitioner can be assured by hearing the characteristic audio signal that the correct medication container has been provided for the patient. Advantageously, the patient identifier is applied by an in-hospital pharmacy to the medication container and corresponds to a patient identifier previously assigned to that patient during pre-treatment processing.
According to still another aspect of the invention, a patient treatment check sheet is provided containing at least a first field for entry of at least the name of the patient to be treated and a second field including printed patient treatment parameters and blanks to be filled in during the course of treatment of the patient, said check sheet further comprising at least one fixed patient identifier including characteristic coding adapted to be scanned by a scanning device to provide reading thereof and at least one removable patient identifier including said characteristic coding and adapted to be affixed to a further element to be used in the treatment of the patient.
Preferably, the further element to which the removable patient identifier is affixed is the patient identification member selected from the group consisting of a patient photograph, a patient chart, a patient treatment verification sheet, a patient identification card, a patient identification band and a combination of a patient photograph and a patient chart.
In accordance with still another aspect of the invention, a verification system is provided for use in verification of the identify of a patient about to undergo medical treatment administered to the patient in a treatment room under the control of at least one medical practitioner, the system comprising: a verification workstation including electronic storing means for storing a patient identifier assigned to the patient to be treated; at least one scanning device for scanning a scannable patient identifier which uniquely identifies the patient to be treated; and means for generating a characteristic audible output assigned to the patient to be treated and unique to the patient, responsive to matching of the patient identifier scanned by said scanning device and the patient identifier stored by said electronic storing means at said verification workstation. Preferably, the scannable patient identifier comprises a bar code carried by a treatment chart for the patient. Advantageously, the system includes first and second scanning devices, located at spaced locations within said treatment room, for separately scanning scannable patient identifiers carried, respectively, by (i) a treatment chart and (ii) at least one other element associated with the patient to be treated.
In accordance with yet another aspect of the invention, a method is provided for facilitating billing for medical treatment services involving treatment of a patient wherein a patient treatment chart is used in conjunction with the treatment of the patient, the method comprising the steps of: logging onto a computerized billing system when the patient treatment chart is located at a predetermined location in a treatment facility; and generating a billing alert in response to said logging on step so as to ensure patient treatment provided at said location will be billed out. In one important embodiment, the logging on step comprises logging on responsive to use of a scanning device located at said predetermined location to scan a patient identifier on said patient treatment chart.
Further features and advantages of the present invention will be set forth in, or apparent from, the detailed description of preferred embodiments thereof which follows.